Safety of Everolimus and Pemetrexed in Lung Cancer Patients

A Phase I Study Investigating the Combination of Everolimus With Pemetrexed in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) Previously Treated With Chemotherapy

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00434174

Enrollment

Registered

2007-02-13

Start date

2006-12-31

Completion date

2010-12-31

Last updated

2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

Lung cancer, Non small cell lung cancer, NSCLC, RAD001, Everolimus, Afinitor, Pemetrexed

Brief summary

This study will evaluate the safety of everolimus in combination with pemetrexed when used as treatment in patients with non small cell lung cancer.

Interventions

DRUGEverolimus

RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. All proposed dose levels in this study can be given as a combination of these dose strengths. Daily doses of 2.5, 5, 7.5 and 10 mg of RAD001 will be given alongside the standard 21-day cycle of pemetrexed.

DRUGPemetrexed

Pemetrexed was supplied to the sites in 500 mg/m2 was administered on Day 1 of each cycle as a 10-minute continuous i.v. infusion in 100mL normal saline

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Lung cancer * Only one prior regimen of chemotherapy for the treatment of non small cell lung cancer * Adequate bone marrow function * Adequate liver function * Adequate renal function * Negative serum pregnancy test

Exclusion criteria

* History of another primary malignancy in the last 5 years * Having recently received an investigational drug * Having recently received major surgery of wide field radiotherapy * Chronic treatment with immunosuppressive therapy, steroids or liver enzyme modulators * Severe or uncontrolled medical conditions Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate.	Over 18 weeks of combination treatment

Secondary

Measure	Time frame
Assess the ability to deliver the standard pemetrexed treatment (relative dose intensity) Assess the pharmacokinetics of everolimus and chemotherapy Evaluate the effect of therapy (RECIST)	Over 18 weeks of combination treatment

Countries

Australia, Belgium, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026